The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial trigger points.

Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch directly to each trigger point identified at the Screening/Baseline Visit (up to 3 trigger points). Patches will be administered for 4 hours, 2 times per day (total of 8 hours for each trigger point per day).

Other Name: Synera

Detailed Description:

The purpose of this pilot study is to explore the usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial trigger points. The study will consist of a 2-week, open-label treatment period followed by a 2 week follow-up period conducted at a single study site. Eligible patients must have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 identifiable myofascial trigger points. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

be at least 18 years of age

have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 myofascial trigger points

have trigger points confined to the upper back, shoulder, and neck

Exclusion Criteria:

have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit

have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit

have used any injected pain medication with 28 days preceding the Screening/Baseline Visit

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01106989